ASH: Seattle Genetics rolls into latest Adcetris launch with double survival win

An Adcetris-containing regimen topped the standard of care at staving off cancer progression and lengthening lives of patients with newly diagnosed peripheral T-cell lymphoma. (Seattle Genetics)

SAN DIEGO—Last month, Seattle Genetics scored an ultrafast FDA nod for Adcetris in patients with newly diagnosed peripheral T-cell lymphoma, and data presented at the American Society of Hematology annual meeting show why.

Late Monday, the biotech rolled out data showing that adding Adcetris to a cocktail of cyclophosphamide, doxorubicin and prednisone (CHP) could top a standard-of-care regimen known as CHOP—which combines CHP and vincristine—not only at keeping disease at bay, as the company had previously disclosed, but also at prolonging patients' lives, too. The Adcetris combo posted a 34% reduction in the risk of death as part of a phase 3 study dubbed Echelon-2.

RELATED: Seattle Genetics' Adcetris scores quick lymphoma OK under FDA's new review program


Striving for Zero in Quality & Manufacturing

Pharmaceutical and medical device manufacturers strive towards a culture of zero – zero hazards, zero defects, and zero waste. This on-demand webinar discusses the role that content management plays in pharmaceutical manufacturing to help companies reach the goal of zero in Quality and Manufacturing.

The expanded data follow Seattle Genetics’ October top-line announcement that Adcetris had reduced the risk of disease progression or death by 29%. Patients in the study’s Adcetris arm lived a median 48.2 months without their cancer worsening, compared with 20.8 months for patients in the CHOP arm, regulators said at the time.

“We more than doubled the median progression-free survival of the standard of care that’s existed for 35 years, and to me, you don’t see that every day,” CEO Clay Siegall, Ph.D., said in an interview over the weekend.

The new ASH results also include secondary endpoint wins for Adcetris. The drug mustered an overall response rate of 83% versus CHOP’s 72%, as well as a complete response rate of 68% compared with the 56% that CHOP put up.

RELATED: Seattle Genetics CEO goes inside its lightning-quick Adcetris nod, courtesy of FDA's real-time pilot

With an FDA approval already in hand, courtesy of the agency's new Real Time Oncology Review pilot program, Seattle Genetics has already begun to roll out Adcetris in its new patient population. The company is fielding a commercial team of about 135 people, 90 of whom are on-the-ground reps, Siegall said.

While the company hasn’t given sales guidance around the launch—it expects to do that on its next quarterly conference call in February—“what I can tell you is we hit the ground running,” Siegall said. The company got a head start on its rep training, meaning it wasn’t blindsided by the FDA’s early OK.

“We wanted to be launch-ready extremely early, and we made that decision a long time ago,” Siegall said, adding, “in hindsight, I’m really glad we” did.

Suggested Articles

Imbruvica has enjoyed a nice run in previously untreated CLL over the last few years. But major competition is here in the form of AZ's Calquence.

Pennsylvania's Supreme Court revived thousands of lawsuits alleging the antipsychotic med Risperdal caused males to develop breasts.

In the asthma biologics race, there doesn't appear to be a clear favorite among Xolair, Dupixent, Fasenra and Nucala for a group of pulmonologists.